Outcomes after angiography with sodium bicarbonate and acetylcysteine

Background: Intravenous sodium bicarbonate and oral acetylcysteine are widely used to prevent acute kidney injury and associated adverse outcomes after angiography without definitive evidence of their efficacy. Methods: Using a 2-by-2 factorial design, we randomly assigned 5177 patients at high risk for renal complications who were scheduled for angiography to receive intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride and 5 days of oral acetylcysteine or oral placebo; of these patients, 4993 were included in the modified intention-to-treat analysis. The primary end point was a composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 days. Contrast-associated acute kidney injury was a secondary end point. Results: The sponsor stopped the trial after a prespecified interim analysis. There was no interaction between sodium bicarbonate and acetylcysteine with respect to the primary end point (P=0.33). The primary end point occurred in 110 of 2511 patients (4.4%) in the sodium bicarbonate group as compared with 116 of 2482 (4.7%) in the sodium chloride group (odds ratio, 0.93; 95% confidence interval [CI], 0.72 to 1.22; P=0.62) and in 114 of 2495 patients (4.6%) in the acetylcysteine group as compared with 112 of 2498 (4.5%) in the placebo group (odds ratio, 1.02; 95% CI, 0.78 to 1.33; P=0.88). There were no significant between-group differences in the rates of contrast-associated acute kidney injury. Conclusions: Among patients at high risk for renal complications who were undergoing angiography, there was no benefit of intravenous sodium bicarbonate over intravenous sodium chloride or of oral acetylcysteine over placebo for the prevention of death, need for dialysis, or persistent decline in kidney function at 90 days or for the prevention of contrast-associated acute kidney injury. (Funded by the U.S. Department of Veterans Affairs Office of Research and Development and the National Health and Medical Research Council of Australia; PRESERVE ClinicalTrials.gov number, NCT01467466.

Reflections: OD or Not OD that is the Question! A Constructivist's Thoughts on the Changing Nature of Change

The landscape of organization development (OD) has changed significantly over the last several decades. This article provides a broad commentary on these changes. In particular, it offers a critique of 'current OD' in terms of the marginalization of materiality in discourse-based OD techniques and the neglect of problem-centred, diagnostic approaches in favour of solution-driven, emergent approaches. The future of OD is also explored in relation to the scope for meaningful 'bottom-up OD' (i.e. employee-instigated change) and 'outside-in OD' (i.e. involving a range of non-organizational stakeholders). © 2013 Taylor & Francis

Patient Discomfort Associated with the Use of Intra-arterial Iodinated Contrast Media: A Meta-Analysis of Comparative Randomized Controlled Trials

<p>Abstract</p> <p>Background</p> <p>Discomfort characterized by pain and warmth are common adverse effects associated with the use of intra-arterial iodinated contrast media (CM). The objective of this review was to pool patient-reported outcomes available from head-to-head randomized controlled trials (RCTs) and to compare the discomfort rates associated with iso-osmolar contrast media (IOCM; i.e., iodixanol) to those reported with various low-osmolar contrast media (LOCM).</p> <p>Methods</p> <p>A review of the literature published between 1990 and 2009 available through Medline, Medline Preprints, Embase, Biological Abstracts, BioBase, Cab Abstracts, International Pharmaceutical Abstracts, Life Sciences Collection, Inside Conferences, Energy Database, Engineering Index and Technology Collection was performed to compare rates of discomfort associated with the use of the IOCM (iodixanol) vs. various LOCM agents in head-to-head RCTs. All trials with a Jadad score ≥2 that reported patient discomfort data following intra-arterial administration of CM were reviewed, coded, and extracted.</p> <p>Results</p> <p>A total of 22 RCTs (n = 8087) were included. Overall discomfort (regardless of severity) was significantly different between patients receiving IOCM and various LOCMs (risk difference [RD] -0.049; 95% confidence interval [CI]: -0.076, -0.021; p = 0.001). IOCM was favored over all LOCMs combined with a summary RD value of -0.188 (95% CI: -0.265, -0.112; p < 0.001) for incidence of pain, regardless of severity. A greater reduction in the magnitude of pain was observed with IOCM (iodixanol), particularly with selective limb and carotid/intracerebral procedures. Similarly, the meta-analysis of warmth sensation, regardless of severity, favored IOCM over LOCMs with an RD of -0.043 (95% CI: -0.074, -0.011; p = 0.008). A positive linear relationship was observed between the discomfort effect size and age and a negative relationship with increasing proportion of women. The opposite trends were observed with warmth sensation.</p> <p>Conclusions</p> <p>IOCM was associated with less frequent and severe patient discomfort during intra-arterial administration. These data support differences in osmolality as a possible determinant of CM discomfort.</p

A study of sertraline in dialysis (ASSertID) : a protocol for a pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis

© 2015 Friedli et al. Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise statedBACKGROUND: The prevalence of depression in people receiving haemodialysis is high with estimates varying between 20 and 40 %. There is little research on the effectiveness of antidepressants in dialysis patients with the few clinical trials suffering significant methodological issues. We plan to carry out a study to evaluate the feasibility of conducting a randomised controlled trial in patients on haemodialysis who have diagnosed Major Depressive Disorder.METHODS/DESIGN: The study has two phases, a screening phase and the randomised controlled trial. Patients will be screened initially with the Beck Depression Inventory to estimate the number of patients who score 16 or above. These patients will be invited to an interview with a psychiatrist who will invite those with a diagnosis of Major Depressive Disorder to take part in the trial. Consenting patients will be randomised to either Sertraline or placebo. Patients will be followed-up for 6 months. Demographic and clinical data will be collected at screening interview, baseline interview and 2 weeks, and every month (up to 6 months) after baseline. The primary outcome is to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in haemodialysis patients with depression. Secondary outcomes include estimation of the variability in the outcome measures for the treatment and placebo arms, which will allow for a future adequately powered definitive trial. Analysis will primarily be descriptive, including the number of patients eligible for the trial, drug exposure of Sertraline in haemodialysis patients and the patient experience of participating in this trial.DISCUSSION: There is an urgent need for this research in the dialysis population because of the dearth of good quality and adequately powered studies. Research with renal patients is particularly difficult as they often have complex medical needs. This research will therefore not only assess the outcome of anti-depressants in haemodialysis patients with depression but also the process of running a randomised controlled trial in this population. Hence, the outputs of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the efficacy of anti-depressants in patient on haemodialysis with depression.TRIAL REGISTRATION: ISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.Peer reviewedFinal Published versio

DNA-Free Recombinant SV40 Capsids Protect Mice from Acute Renal Failure by Inducing Stress Response, Survival Pathway and Apoptotic Arrest

Viruses induce signaling and host defense during infection. Employing these natural trigger mechanisms to combat organ or tissue failure is hampered by harmful effects of most viruses. Here we demonstrate that SV40 empty capsids (Virus Like Particles-VLPs), with no DNA, induce host Hsp/c70 and Akt-1 survival pathways, key players in cellular survival mechanisms. We postulated that this signaling might protect against organ damage in vivo. Acute kidney injury (AKI) was chosen as target. AKI is critical, prevalent disorder in humans, caused by nephrotoxic agents, sepsis or ischemia, via apoptosis/necrosis of renal tubular cells, with high morbidity and mortality. Systemic administration of VLPs activated Akt-1 and upregulated Hsp/c70 in vivo. Experiments in mercury-induced AKI mouse model demonstrated that apoptosis, oxidative stress and toxic renal failure were significantly attenuated by pretreatment with capsids prior to the mercury insult. Survival rate increased from 12% to >60%, with wide dose response. This study demonstrates that SV40 VLPs, devoid of DNA, may potentially be used as prophylactic agent for AKI. We anticipate that these finding may be projected to a wide range of organ failure, using empty capsids of SV40 as well as other viruses

Rethinking ‘Organizational Effectiveness’ as a Core Premise of Organization Development: Beyond Narrow Organizational Interests and Towards Wider Soulful Interventions

We contend that the dominant focus within the OD discourse is on organizations and their success (i.e. a preoccupation with ‘organizational effectiveness’) at the expense of wider responsibilities and obligations, and that the framing of ‘organizational health’ is overly narrow and partial (i.e. what is healthy for the organization rather than what is ‘healthy’ at an individual or societal level). We offer some support for our assertion that OD initiatives focus too much on organizational effectiveness and organizational health and we discuss the scope for embracing a wider set of change imperatives. This involves distinguishing between ‘self-ish’ and ‘self-less’ behaviour and drawing a distinction between distributive and generative forms of change activity Finally, we conclude by briefly sketching out how this could take shape in terms of what we have chosen to call ‘soulful interventions’. MAD statement: This opinion piece seeks to Make a Difference (MAD) by challenging the focus on organizational effectiveness and organizational health in organization development (OD) interventions. In doing so, we make a case for utilizing a wider set of change imperatives (e.g. increasing sustainability, enhancing social responsibility, addressing community needs) and set out how this should take shape in terms of a more inclusive and socially-informed bundle of approaches to OD

Reframing the university as an emergent organization: implications for strategic management and leadership in higher education

For the most part, the organisational forms that are currently being adopted by higher education institutions are grounded in the traditional corporate models of organisation that take a rational approach to organisational design and change management. Underlying this account is an assumption of organisational autonomy and the capacity of designated leaders to direct change processes to better align their institutions with societal demands or goals. However, a case is now being made for the consideration of alternative organisational theories or models that offer a different perception on the sources and patterns of organisational change in higher education. These theories perceive organisations more as emergent entities in which change is continuous, often unpredictable and arising mainly from local interactions. The paper surveys the implications that acceptance of the alternative paradigm might have for strategising and change leadership in higher education institutions. It suggests that the accommodation of these alterative paradigms of institutional development in higher education may itself be an emergent process and considers how future research and policy formulation relating to strategic management and leadership might facilitate positive outcomes in that process

Group Support Systems: experiments with an online system and implications for same-time/different places working

This is the author accepted manuscript. The final version is available from Springer via the DOI in this recordWe present an analysis of the Group Explorer Group Support System (GSS) from the perspective of its implementation as technology that can support same-time/different-places group workshops. The purpose of the chapter is to report on our experiences with using a same-time/different places GSS, introduce issues that arise from these experiences, and discuss future prospects. The chapter commences by reviewing our current understanding of GSS and how they support the use of distributed Problem Structuring Methods (PSMs) in both single organization and multi-organization settings. The configuration and use of a cloud-based online version of the GSS is presented that highlights some of the key technological, organisational and facilitation issues involved in supporting distributed PSM workshops. The future development of such online GSS is discussed with a particular focus on two emerging research questions; the future role of the facilitator in online GSS, and the commonalities between online GSS and social media platforms as different-times/different-places group working, such as crowdsourcing, become prevalent in the context of increasing globalisation and the ongoing decentralisation of work environments.Engineering and Physical Sciences Research Council (EPSRC)Natural Environment Research Council (NERC)European Union FP7European Union Horizon 202